Can Post Filing Data Overcome Inventive Step in China?
Since 2010, the Patent Re-examination Board (PRB) has published the top 10 patent invalidation cases of the year in April of each year. The selection criteria are high social concern, significant impact on the related industry, or involve difficult legal issues and important examination criteria. Below is one of the top 10 cases that discusses post filing data in China patents.
Post Filing Data in China
Can post-filing data showing unexpected technical effect be used to overcome inventive step if the specification contains no data but asserts the unexpected technical effect?
In short, the answer is no, post-filing data cannot be used to overcome inventive step even if the idea was asserted if the original data was not in the application.
Novartis’s Chinese patent (201110029600.7) claimed the combination of AT 1-antagonist valsartan and NEP inhibitor Sacubitril. The specification asserted that the combination of the two drugs had synergistic effect, yet provided no data at the time of filing.
The PRB sided with petitioner Dai Jinliang and argued that one of skill in the art could not predict that the combination would be synergistic without experimental data. In other words, applicants had not solved the technical problem of providing a pharmaceutical combination with synergistic effects. At most, applicants had provided a pharmaceutical composition for treating hypertension. In January of 2018, the PRB declared that the Novartis patent was invalid.
In our experience, if experimental data is in the application as filed but another piece of prior art is cited during prosecution, the applicant may submit post-filing data showing results of comparison studies with the newly discovered art, provided that the original data for applicant’s invention was already disclosed in the application as filed.
About the Author
Jennifer Che, J.D. is a US Patent Attorney and Vice President and Partner at Eagle IP, a Boutique Patent Firm with offices in Hong Kong, Shenzhen, and Macau.[email protected]This article is for general informational purposes only and should not be considered legal advice or a legal opinion on a specific set of facts.
Other Articles
Do Promotional Marketing Materials Constitute an “Offer for Sale” under Chinese Patent Law? Bayer IP GmbH v. Nanjing Hang Seng Pharmaceutical
12 December 2023
Bayer's blockbuster drug Rivaroxaban has seen its share of patent litigations in China, several of which are big enough to be listed as Top 10 IP cases or 50 Representative IP cases. We summarized an invalidation case back in 2020 where all of Bayer’s claims directed towards the compound were upheld. Recently, another Rivaroxaban case […]
Read more >
CHINA: How Prohibiting "Illegal" Inventions Runs into Food Safety Law
22 October 2021
Chinese Patent Law has an interesting provision that specifically prohibits patent protection on “illegal” or “immoral” inventions. What does this mean, exactly? According to Article 5.1 of the Chinese Patent Law, “no patent shall be granted for an invention that contravenes any law or social moral or that is detrimental to public interests.” On its […]
Read more >
Burden Shift: CNIPA Requires Applicant to “Prove” that Post-Filing Data is not Fake Data
1 April 2025
“Good Faith” is a challenging concept that brings with it the nuances of a particular jurisdiction’s ideas about honesty, moral values, and societal expectations. Most patent laws around the world include good faith requirements – especially in matters involving the legal and the medical profession – and China is no exception. So what’s the standard? […]
Read more >
2019 CHINA TOP 10 IP CASE: VALEO V. LUCAS, FUKE, & CHEN
8 June 2020
Every year in the spring The Supreme People’s Court of PRC announces its “Top 10 Intellectual Property (IP) cases” and “50 typical IP cases in Chinese courts” of the year. Although not having precedential weight, these cases serve as a reference and guide people's courts at all levels regarding their intellectual property trials. It’s always […]
Read more >
Our Past Events
Eagle IP is Coming Back to LSPN in Boston!
24 April 2025
AIPLA Women in IP Global Networking Event in Hong Kong
3 April 2025
Talk at Hong Kong Christian Service
31 October 2024
Talk for HKUST Entrepreneurship 101 Training Program
31 October 2024
IP Training Programme on patent commercialization and technology transfer
